# China NMPA Product Recall - Prothrombin Time and Fibrinogen Assay Kit (Coagulation Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/instrumentation-laboratory-co/6f575a12-60f1-450e-9d09-faae763572ad/
Source feed: China

> China NMPA product recall for Prothrombin Time and Fibrinogen Assay Kit (Coagulation Method) by Instrumentation Laboratory Co. published October 30, 2017. Recall level: Level 2 Recall. Instrumentation Laboratory Co., through its agent Wofen Medical Device Trading (Beijing) Co., Ltd., 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Instrumentation Laboratory Co. is voluntarily recalling its prothrombin time and fibrinogen assay kits (coagulation method).
- Company Name: Instrumentation Laboratory Co.
- Publication Date: 2017-10-30
- Product Name: Prothrombin Time and Fibrinogen Assay Kit (Coagulation Method)
- Recall Level: Level 2 Recall
- Recall Reason: Customer reports regarding performance issues with the Prothrombin Time and Fibrinogen Assay Kit (Coagulation Method) have revealed problems such as kits exceeding quality control limits and sample results being too long. Investigation has identified two additional affected batches, N0278358 and N0479057.
- Discovering Company: Wofen Medical Equipment Trading (Beijing) Co., Ltd.
- Manufacturing Company: Instrumentation Laboratory Co.
- Summary: Instrumentation Laboratory Co., through its agent Wofen Medical Device Trading (Beijing) Co., Ltd., initiated a Level II voluntary recall for its Prothrombin Time and Fibrinogen Assay Kits (Coagulation Method) (Registration Number: "国械注进20152402017"). The recall was prompted by customer reports detailing performance issues, specifically some kits exceeding quality control limits and yielding excessively long results. Two additional affected batches, N0278358 and N0479057, were identified, impacting 1156 units globally, with 150 units sold in China. Under the National Medical Products Administration (NMPA) framework, Wofen Medical Device Trading (Beijing) Co., Ltd. ceased sales of the problematic batches in China, issued recall notices to customers requesting the return of affected products for replacement, and ensured the destruction of all remaining inventory and recalled kits. These actions were taken to prevent inaccurate diagnostic results for patients.

Company: https://www.globalkeysolutions.net/companies/instrumentation-laboratory-co/fe42e432-39e1-4428-9245-848558cb2c0a/